We test water for endotoxins for a non-sterile API that is sold for further processing to produce a sterile product. Should we also test the API itself for endotoxins?

It would probably be a normal expectation that there would be an endotoxin limit on an API that is
being used for making a sterile injectable product, unless there’s something unusual about the
material or process. If you have an endotoxin specification, you have to test for it. However, if
you’ve been able to convince the regulators in your filing that you do not need that specification
for endotoxins on the API, then there’s nothing in Q7A that says you have to test.